This invention relates to a vascular compression apparatus and method for controlling bleeding and achieving hemostasis by applying pressure onto an area of a patient including a wound site, such as a blood vessel puncture, and a blood vessel. In particular, this invention relates to a vascular compression device and a method for controlling bleeding and facilitating hemostasis following percutaneous catheterization via the femoral artery or vein.
The femoral artery is a high pressure blood vessel which generally requires direct pressure to achieve hemostasis (cessation of bleeding) following completion of a catheterization or cannulation procedure. If, for example, a sheath is removed from the femoral artery in the groin and no attempt to stem the bleeding is made, the patient would quickly experience severe bleeding which would resort in significant consequences including hypovolemia, shock, and possibly death. Hemostasis can often be achieved by applying pressure directly over the femoral artery as well as proximal and medial to the femoral artery puncture site, where such pressure slows or completely occludes blood flow in the artery. This permits a clot to form which causes hemostasis at the puncture site.
Traditionally, to achieve sufficient pressure, an individual must actively press down directly over the artery and proximal and medial to the puncture site for a period of time which varies based on the type of procedure, the nature of the drugs administered and the patient's condition—often for 30 minutes or longer. This can result in fatigue, stiffness and/or pain in the fingers, hands, wrist and forearms of the individual performing the procedure. Prolonged or repeated performance of this procedure may result in a repetitive stress injury such as carpal tunnel syndrome. The direct pressure method also puts the individual administering pressure at risk for direct exposure to the patient's blood.
Various types of automated manual solutions have been developed to, in part, address these issues. One example of an automated solution is shown by Petersen in U.S. Pat. No. 5,554,168. Petersen describes a free standing apparatus which may be attached to the bottom frame of a hospital bed. A pressure applying head is mounted on a swing arm attached to the vertical shaft of the base and can be positioned directly above the wound. Pressure is developed by either compressed air or an electric motor. Two pressure shoes can be positioned to provide both vertical and horizontal pressure.
Another automated solution is described by Lee in U.S. Pat. No. 5,133,734. Lee discloses a pneumatically operated femoral artery compressor applying calibrated and calibrateable external pressure on the puncture site of the femoral artery with the plunger end of a mounted pressurized assembly.
Breen et. al describe another type of partly automated solution, which also uses pneumatic pressure, in U.S. Pat. No. 5,762,173. Breen describes a wound closure device that includes an inflatable balloon with an inflation and deflation outlet. The balloon is coupled to patch, having an aperture for receiving the inflation/deflation outlet. The assembly is coupled to the placement patch and is held via a belt strap at either the wound site or on a bleeding vessel.
These automated compression devices are far from ideal, however. They tend to be expensive, difficult to maintain in good working order, consume a great deal of space and are difficult to keep sterile.
A number of manual compression devices have been described as well. Roth, in U.S. Pat. No. 5,263,965, describes a device that is used to apply direct pressure to arterial and venous incisions to promote hemostasis. It consists of a round flat disk with a user manipulable member used for applying downward pressure. In the preferred embodiment of the invention, the user manipulable member consists of a peg over which a cylindrical weight is pivotally mounted. A stretchable bandage is used to secure the weight in place.
Another type of manual compression device is described by Toller in U.S. Pat. No. 5,342,388. This manual compression aid is comprised of a cylindrically shaped handle above a sterile disposable disk. The disk is placed above the catheter insertion point with the catheter inside the notch of the disk. As the catheter is removed, pressure is applied to the handle to force the disk to compress the artery and thereby control bleeding—ultimately achieving hemostasis. This type of device has a number of disadvantages including: the cost of the apparatus; the difficulty associated in ensuring a minimal level of cleanliness; and the time associated in connecting the disposable disk to the assembly prior to its use on a patient.
Benz et. al describe another form of manual compression device in Pub No. US 2003/0028214. This manual vascular compression device also includes a handle an elongated shaft and a pad or disk. In this device the pad or disk is integral to the assembly and the entire apparatus is disposable. Like the pad of Toller, the pad is flat and contains a notched or equivalent area for locating the catheter.
All these devices, however, provide for straight vertical compression at a single location. This type of compression provides for suboptimal control of the artery or vein ultimately extending the time for achieving hemostasis.